FDA.reportPublic FDA data

NDC 65862-784-10 - Esomeprazole Magnesium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
65862-784
Requested NDC
65862-784-10
Package NDCs from labels
65862-784-30, 65862-784-90, 65862-784-01, 65862-784-99, 65862-784-10, 65862-784-78
Manufacturer
Aurobindo Pharma Limited
Effective date
2025-03-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Esomeprazole Magnesium - Aurobindo Pharma LimitedAurobindo Pharma Limited2025-03-26Human Prescription Drug Label
Esomeprazole Magnesium - NCS HealthCare of KY, LLC dba Vangard LabsNCS HealthCare of KY, LLC dba Vangard Labs2024-09-16HUMAN PRESCRIPTION DRUG LABEL
Esomeprazole Magnesium - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2020-05-14HUMAN PRESCRIPTION DRUG LABEL
Esomeprazole Magnesium - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2018-01-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-784-01Esomeprazole Magnesium100 in 1 BOTTLECAPSULE, DELAYED RELEASE10015
65862-784-10Esomeprazole Magnesium10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1015
65862-784-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE3015
65862-784-78Esomeprazole Magnesium10 in 1 CARTONCAPSULE, DELAYED RELEASE1015
65862-784-90Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE9015
65862-784-99Esomeprazole Magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-784ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 6 package rows20250417_f4ae091d-9b74-4a0e-ac68-057effd91e17.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-784-30EA - Each65862-78487b9131b-9e7a-48ca-820b-83be58b67c9112016-12-07
65862-784-90EA - Each65862-78474b427bf-b382-462b-840f-177111a0114712016-12-07

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 296 of 317 · 6,337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lavender Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.f87f4df2-a595-45e7-b1d0-8f0247c270932023-10-26WarningsExact identifier
unii: 3K9958V90M
Jasmine Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.a1d07799-1b5d-464f-bfe3-3779706375d82023-10-26WarningsExact identifier
unii: 3K9958V90M
Rose Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.b986a0e8-aadf-44dd-a1a8-dcea7c1e66b52023-10-26WarningsExact identifier
unii: 3K9958V90M
Zeyco Antiseptic Hand Sanitizer GelALCOHOLLaboratorios Zeyco, S.A. de C.V.a85df538-dedd-7617-e053-2995a90a4a362023-10-26WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.ad14b387-e280-8dab-e053-2995a90a590c2023-10-26WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.a58cf759-0485-6740-e053-2a95a90a8b432023-10-26WarningsExact identifier
unii: 3K9958V90M
Zeyco Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.aa073f96-5774-c12f-e053-2a95a90aec222023-10-26WarningsExact identifier
unii: 3K9958V90M
Monarch Hand SanitizerALCOHOLLaboratorios Zeyco, S.A. de C.V.aa920f62-352c-4c67-9575-e78f12edef842023-10-26WarningsExact identifier
unii: 3K9958V90M
INSTANT FREE HAND SANITIZERALCOHOLTravel Retail Global Inca3ffa72b-b7d4-463a-a880-66081f16bd1a2023-10-26WarningsExact identifier
unii: 3K9958V90M
SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDETHE KROGER COMPANYa52872bf-cd0f-06da-e053-2995a90af28d2023-10-26WarningsExact identifier
unii: 15FIX9V2JP
PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCe87c4a76-5f21-4989-a1e0-0b7c6902f2012023-10-26WarningsExact identifier
unii: 15FIX9V2JP
Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDENATURA BISSE INTERNATIONAL SAbf8b71c7-257b-0eb6-e053-2a95a90a3a4c2023-10-26WarningsExact identifier
unii: 15FIX9V2JP
Justice Berry Scented Anti-bacterial Hand SanitizerALCOHOLTween Brands, Inc.8a465ff2-5cb5-43bc-a9a7-d4e2162ac90d2023-10-25WarningsExact identifier
unii: 3K9958V90M
Justice 198824 You Rock Antibacterial Cotton Candy Blueberry Hand SanitizerALCOHOLTween Brands,Inc.84c4fb4b-9f63-4414-b8f3-39f65212f22a2023-10-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLBath Concept Cosmetics (Dongguan) Co., Ltd065e083f-3c13-495d-8619-df45c5fce68b2023-10-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLIn Designs Global LLCa2dcedcd-e071-176e-e053-2a95a90a176b2023-10-25WarningsExact identifier
unii: 3K9958V90M
Artnaturals Scent Free Hand SanitizerALCOHOLVirgin Scent Inca2dd4b1d-6a46-2109-e053-2995a90aea082023-10-25WarningsExact identifier
unii: 3K9958V90M
Slight Scent Hand SanitizerALCOHOLSobe Promos LLCa2dd3912-9ecb-22bf-e053-2995a90a08c22023-10-25WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLICARCOVER INC.7aae2f7a-39ce-434e-be0e-bccb04a828642023-10-25WarningsExact identifier
unii: 3K9958V90M
Antiseptic Antibacterial Hand SanitizerALCOHOLVirus Protection Systems,LLCf7348acc-8c8c-45ff-b282-dfcfde8b0aee2023-10-25WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.